New Delhi, April 18 (IANS) Major drug maker Lupin on Saturday said that the US health regulator has issued a ‘Form 483’ with three observations to its manufacturing facility in Somerset, New Jersey, following a recent inspection.In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.”The inspection was completed with the issuance of a Form 483 carrying three observations,” th…
Latest US Food and Drug Administration News & Updates
New Delhi, April 1 (IANS) Association of PET Recyclers (APR) Bharat on Wednesday said that the government guidelines mandating brands and producers to use 40 per cent recycled content in food‑grade PET packaging effective April 1 will boost India’s circular economy, a report said on Wednesday.The move marks a significant milestone in the country’s commitment to sustainable resource management amidst global supply disruptions and geopolitical uncertainties impacting the availability and prici…
New Delhi, March 16 (IANS) Industry body Association of PET Recyclers (APR) Bharat on Monday welcomed FSSAI’s grant of final authorisations to 17 recycled PET manufacturing plants, which will strengthen India’s packaging supply chain.The government’s move will unlock about 3 lakh tonne per annum of food‑grade r‑PET capacity to help meet the government’s mandate of 40 per cent recycled content by 2026‑27, the statement from APR Bharat said.The approvals create a combined FSSAI-authorise…
New Delhi, Jan 26 (IANS) Indian drugmakers Sun Pharmaceutical Industries and Cipla have recalled certain products from the US market due to manufacturing-related issues, according to the latest update from the US Food and Drug Administration (USFDA).In its Enforcement Report, the US health regulator said the US-based arm of Mumbai-headquartered Sun Pharma is recalling more than 26,000 bottles of a generic medicine used to treat dandruff and skin conditions that cause inflammation and itching.Sun…
Washington, Jan 15 (IANS) An Indian American obstetrician and gynaecologist pushed back against political framing on abortion, urging lawmakers to focus on medical science and patient safety rather than ideological disputes. Testifying before the Senate Health, Education, Labour and Pensions Committee, obstetrician and gynaecologist Dr Nisha Verma said abortion medication has been widely studied and safely used for decades, warning that restrictions driven by politics are causing harm.“Medicat…
New Delhi, Jan 2 (IANS) The US Food and Drug Administration’s (FDA) approval of the first-ever oral pill for anaemia in adults with thalassemia marks a historic milestone and can be a game changer in the management of the genetic blood disorder, said health experts on Friday.The FDA recently approved mitapivat (to be marketed under the brand name Aqvesme) for the treatment of anemia in adults with alpha- or beta-thalassemia.Mitapivat is the first medication indicated for both transfusion-depen…
New Delhi, Dec 29 (IANS) New Year is the time for many people to pledge reforms in habits and lifestyle, something resorting to drastic measures, but UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has urged the people to make sure any weight-loss medicines they use are safe, effective and legitimate. The MHRA has warned about the serious risks linked to buying weight-loss products from unregulated websites or through social media, where products sold illegally may be fake, conta…